Table 1

Demographic and clinical characteristics (mITT population)

VariableTest 1 (n=88)Test 2 (n=75)Control (n=93)
Integer age*
 Mean, years (SD)8.0 (1.2)8.2 (1.2)8.2 (1.2)
 Age group, n (%)
 6 years10 (11.4)8 (10.7)9 (9.7)
 7 years20 (22.7)13 (17.3)18 (19.4)
 8 years23 (26.1)17 (22.7)24 (25.8)
 9 years27 (30.7)28 (37.3)32 (34.4)
 10 years8 (9.1)9 (12.0)10 (10.8)
Sex, (n (%))
 Male39 (44.3)29 (38.7)39 (41.9)
 Female49 (55.7)46 (61.3)54 (58.1)
Ethnicity, (n (%))
 Hispanic or Latino18 (20.5)10 (13.3)17 (18.3)
 Not Hispanic or Latino70 (79.5)65 (86.7)76 (81.7)
Race
 White64 (72.7)55 (73.3)71 (76.3)
 Black or African American19 (21.6)13 (17.3)17 (18.3)
 American Indian or Alaska Native2 (2.3)1 (1.3)2 (2.2)
 Asian Indian1 (1.1)5 (6.7)2 (2.2)
 Chinese2 (2.3)2 (2.7)3 (3.2)
 Filipino0 (0)1 (1.3)0 (0)
 Japanese0 (0)1 (1.3)1 (1.1)
 Other Asian2 (2.3)2 (2.7)3 (3.2)
 Native Hawaiian or Other Pacific Islander1 (1.1)0 (0)0 (0)
Myopic parents, n (%)
 Two29 (33.0)36 (48.0)34 (36.6)
 At least one7 (8.0)8 (10.7)10 (10.8)
 One36 (40.9)22 (29.3)42 (45.2)
 Zero9 (10.2)8 (10.7)7 (7.5)
 Unknown7 (8.0)1 (1.3)0 (0)
Axial Length, mm (mean (SD), range)24.09 (0.82)
22.03 to 26.25
23.94 (0.70)
22.33 to 25.42
24.03 (0.78)
22.13 to 25.72
Cycloplegic SER, D (mean (SD), range)§ −2.00 (0.93)
−4.52 to −0.19
−1.85 (0.91)
−4.60 to −0.50
−1.95 (1.02)
−4.94 to −0.38
  • *Integer age is the subject’s age rounded down to the nearest whole year.

  • †Proportion may not sum to 100% as subjects selecting more than one race will be counted multiple times.

  • ‡Subjects/parents were given the options: unknown, zero, one, at least one or two.

  • §Subjects were screened based on manifest refraction and were required have at least −0.75 D SER, however, in a small number of cases the cycloplegic SER revealed less myopia.

  • mITT, modified intent to treat; SER, spherical equivalent refractive error.